Access Thyroxine Assay

• • Terminated Z-1949-2011 FDA Unclassified (pre-2012) ·initiated 10 Mar 2011

  The recall was initiated because the concentration of total T4 in samples from pregnant women is erroneously low (20%) when measured using the Access Total T4 assay. Erroneously low results which are actually high (outside of the normal reference range) could mask hyperthyroidism. Failure to diagnose or treat hyperthyroid disease associated with pregnancy could result in serious, permanent harm

Full name

Access(R) Thyroxine Assay

510(k) Number

K926475 ↗

FDA Product Code

KLI

Device Class

Class II

Regulation

21 CFR Part 862.1700

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

• Kallestad Rsv Microplate Eia

  Class I

  FDA 510(k) K924289 Active Cleared 12 Feb 1993

• Access(R) Total Ige Assay

  Class II

  FDA 510(k) K930984 Active Cleared 9 Jun 1993

• Access Troponin I Reagents on the Access Immunoassay Analyzer Model Numbers: 33320, 33325 and 33329

  Class II

  FDA 510(k) K963934 Active Cleared 16 Dec 1996

• Bioplex 200 Ana Screen on the Bioplex 2200 Multi-Analyte Detection System, Model Bioplex 2200

  Class II

  FDA 510(k) K041658 Active Cleared 20 Dec 2004

• Bioplex 2200 Celiac Iga and Igg Kits on the Bioplex 2200 System, Bioplex 2200 Celiac Iga and Igg Calibrator Sets, and Bi

  Class II

  FDA 510(k) K130053 Active Cleared 19 Sep 2013

• Access Ck-Mb Reagents

  Class II

  FDA 510(k) K945083 Active Cleared 21 Nov 1994

See all devices from Bio-Rad Laboratories, Inc. →

• What is the ACCESS(R) THYROXINE ASSAY used for?

  The ACCESS(R) THYROXINE ASSAY is an enzyme immunoassay, non-radiolabeled, used to quantitatively determine thyroxine levels in human serum or plasma specimens. It is intended for professional laboratory use in clinical settings to support the assessment of thyroid function through total thyroxine measurement.

• How is the ACCESS(R) THYROXINE ASSAY supplied and what system is it designed for?

  The ACCESS(R) THYROXINE ASSAY is supplied as a reagent kit specifically designed for use with the Access immunoassay system. This format ensures compatibility and reliable performance when running the assay in a clinical laboratory environment.

• Is the ACCESS(R) THYROXINE ASSAY a single-use or reusable device?

  The ACCESS(R) THYROXINE ASSAY is supplied as a reagent kit for in vitro diagnostic use, meaning the reagents are consumed during the assay process and are not intended for reuse. Each test requires fresh reagents to ensure accurate and reliable quantitative measurement of thyroxine in serum or plasma specimens.